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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
510(k) Number K843441
Device Name URINARY DRAINAGE CONTAINER 2012-WITH
Applicant
Vital Metrics, Inc.
6341 Nancy Ridge Dr.
San Diego,  CA  92121
Applicant Contact ANNE WISTER
Correspondent
Vital Metrics, Inc.
6341 Nancy Ridge Dr.
San Diego,  CA  92121
Correspondent Contact ANNE WISTER
Regulation Number876.1800
Classification Product Code
FFG  
Date Received09/04/1984
Decision Date 01/03/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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